CLARISCAN gadoteric acid 1.397g/5mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gadoteric acid, Quantity: 279.32 mg/mL

Available from:

GE Healthcare Australia Pty Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: meglumine; water for injections; tetraxetan

Administration route:

Intravenous

Units in package:

10

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

Clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

Product summary:

Visual Identification: Clariscan is a clear, colourless to yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-01-11

Patient Information leaflet

Clariscan - Consumer Medicine Information
Page 1 of 3
CLARISCAN
®
INJECTION
_GADOTERIC ACID_
CONSUMER MEDICINE INFORMATION (CMI)
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic
systemic fibrosis (NSF) in
patients with:
•
acute or chronic severe renal insufficiency (glomerular filtration
rate <30 mL/min/1.73m
2
), or
•
acute renal insufficiency of any severity due to the hepato-renal
syndrome or in the perioperative
liver transplantation period.
WHAT
IS
IN
THIS
LEAFLET
This leaflet provides only a
summary of the information
known about Clariscan.
It
does
not
contain all
the
available information. It
does
not take
the
place of
talking to your doctor or
health care professional.
All
diagnostic
agents
have
risks
and
benefits.
Your
doctor has weighed the risks
of
you
using
Clariscan
against
the
benefits
it
is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS DIAGNOSTIC
AGENT, ASK YOUR DOCTOR OR
RADIOLOGIST.
IF YOU HAVE ANY QUESTIONS,
WANT TO KNOW MORE ABOUT
CLARISCAN
OR
ARE
UNSURE
ABOUT
ANYTHING,
ASK
YOUR
SPECIALIST OR RADIOLOGIST.
KEEP THIS LEAFLET.
You may need to read it
again.
Remember
that
this
injection
is
only
for
you.
Only a doctor can prescribe
it for you.
WHAT CLARISCAN IS USED
FOR
Clariscan contains gadoteric
acid, which is made from
gadolinium
oxide
(a
magnetic
agent)
and
DOTA, which binds with
the
gadolinium
oxide
to
make a contrast agent to help
diagnosis in MRI (magnetic
resonance imaging).
This
is
injected
into
your
veins
just
before
a
MRI
examination.
MRI is a form of medical
diagnostic
imaging
that
forms
pictures
after
detecting water molecules in
normal
and
abnormal
tissues. This is done using a
complex system of magnets
and radiowaves.
BEFORE
YOU
ARE
GIVEN CLARISCAN
_WHEN YOU MUST NOT BE _
_GIVEN IT_
YOU MUST NOT BE GIVEN
CLARISCAN IF YOU HAVE:
•
EVER HAD AN ALLERGIC
(HYPERSENSITIVE)
REACTION TO THE ACTIVE
SUBSTANCE,
GADOTERIC
ACID, OR TO THE OTHER
INGREDIENTS IN CLARISCAN.
Symptoms of an allergic
reaction
may
includ

Summary of Product characteristics

Page 1 of 11
PRODUCT INFORMATION
CLARISCAN
Gadoteric acid
0.5 mmol/ mL solution for injection
Gadoteric acid
0.5 mmol/ mL solution for injection in pre-filled syringe NAME OF TH E MEDICINE
Clariscan (gadoteric acid) paramagnetic contrast medium for Magnetic
Resonance Imaging (MRI). The
structural formula of gadoteric acid is shown below:
CHEMICAL NAME: GADOTERIC ACID
FORMULA C
16
H
25
GdN
4
O
8
MOLAR MASS 558.64 g/mol
The CAS Registry Number is 72573-82-1. DESCRIPTION
Clariscan is a clear, colourless to yellow solution available in glass
vials or pre-filled syringes intended
for intravenous injection.
Each vial or pre-filled syringe contains the active ingredient
gadoteric acid 279.32 mg/mL (0.5 M).
Gadoteric acid is a 1:1 complex of the paramagnetic ion gadolinium
oxide 90.62 mg/mL with tetraxetan
(1,4,7,10–tetraazacyclododecane–N,N’,N’’,N’’’–tetraacetic
acid or DOTA) 202.46 mg/mL. Clariscan
also contains the excipients
meglumine 97.6
mg/mL, excess tetraxetan 0.25 mg/mL and water for
injections.
Page 2 of 11
Chemical characteristics of the formulation:
•
The product is hypertonic with tonicity 4.6 times that of the plasma
(Osmolality:1350 mOsm.kg
-1
,
)Viscosity at 20°C: 3.2 mPa.s, Viscosity at 37°C: 2.0 mPa.s, pH: 6.5
– 8.0
•
Density of solution: 1.349g/mL
PHARMACOLOGY
Gadoteric acid has paramagnetic properties which increase contrast
enhancement in magnetic
resonance imaging. The presence of 7 unpaired electrons in the
gadolinium outer shell explains that
this ion has a high magnetic moment and thus a strong paramagnetic
effect. Gadoteric acid shortens
the longitudinal relaxation time (T1) and the transverse relaxation
time (T2) of water protons in tissues
where it is distributed. At clinical doses the major effect is on T1
relaxation time. This results in an
increased signal intensity in T1-weighted sequences and allows a
better visualisation of abnormal
structures or lesions.
Gadoteric acid has no specific pharmacodynamic activity and is
biologically inert.
PHARMACOKINETICS:
After i